The present invention, in some embodiments thereof, relates to the field of surgically created openings for waste removal (stoma) in living subjects, and more particularly, to devices and methods for covering a stoma as may be used in the case of a colostomy, ileostomy or urostomy.
In performing an ostomy, the physician will generally form the stoma in the abdominal wall and attach an end or a side of a healthy portion of the intestine (large or small intestine, depending on the type of ostomy) to the stoma from the visceral side of the abdominal wall or, alternatively, pass the intestinal portion through the stoma and attach it to the outside of the abdominal wall. The stoma may be permanently left in a patient suffering from a condition for when it is no longer possible for the intestinal content to pass out via the anus, for example, due to colon cancer, diverticulitis, trauma, or inflammatory bowel disease, or may be temporary, as may be the case following an operation on a section of the bowel (small intestine and/or large intestine) requiring a healing period.
During or following the surgical procedure, an invasive ostomy port may be temporarily or permanently inserted through the stoma for conducting the body wastes from the intestine through the stoma. The invasive ostomy port may also serve to prevent the body wastes from coming in contact with the external abdominal wall as they are expelled through the stoma. Such an invasive ostomy port, in various embodiments thereof, is described by the Applicant in WO 2011/13872 A2, incorporated herein by reference in its entirety.
A waste collection bag (also known as “pouch”) is frequently attached to the invasive ostomy port on the side of the external abdominal wall for collecting the waste content flowing through the port. The pouch may be of a disposable type or may be reusable following emptying of its contents.
In some ports, either invasive or non-invasive, a cap is removably attached to the port for maintaining the port sealed and the waste content inside. When required, the user removes the cap and attaches the pouch, replacing the cap following the port having been substantially emptied from the accumulated waste content.
Alternatively to the use of the invasive ostomy port and possibly more popular due to its simplicity and comparatively low cost is the non-invasive ostomy port such as ostomy wafer (also known as “skin barrier” or “faceplate”) or ostomy belt. Such a wafer is typically a patch which is placed over the stoma on the external abdominal wall and protects the skin around the stoma from coming into contact with the waste content. The wafer typically includes an adhesive on one side for removably adhering it to the abdominal wall. It generally includes a flange or other pouch attachment element to which a pouch may be either removably or permanently attached. The combination of a wafer with a removable pouch is generally referred to in the art as an ostomy “two-piece” system whereas that of a wafer with a fixed, non-removable pouch is generally referred to as an ostomy “one-piece” system. The wafer also includes a wafer port peripherally surrounded by the flange and in fluid communication with the stoma for allowing waste content flow from the stoma into the pouch. One requirement of the wafer port is that it be sized to accommodate a portion of the stoma which may protrude from the abdominal wall. Some wafers may be available in different sizes and/or may have different sized ports so that a user may select a wafer with a suitably sized port. Other wafers may include a wafer port template so that the user may cut an opening in the template suitable for accommodating the stoma. Still other wafers may include wafer ports which may be manually shaped by the user to accommodate the stoma.
In addition to the one-piece and the two-piece system described above, other non-invasive ostomy ports are known in the art. Some example are described in U.S. Pat. No. 7,250,040 to Andersen; U.S. Patent Application Publication Number 2004/0181197, 2007/0088300, and 2007/0191794, to Clive et al.; and U.S. Pat. No. 6,689,111 to Mulhauser et al.
U.S. Pat. No. 7,250,040 relates to “an arrangement at a stoma bag of the type used by persons or animals with a colostoma, including a flexible bag (flexibag) and a ring fastener/magazine ring, where the ring fastener/magazine ring is designed to be connected to a stoma plate, and where, in its initial position, the entire flexibag is located in or in close proximity to the ring fastener/magazine ring.”
U.S. Patent Application Publication Number 2004/0181197 relates to “a flexible membrane is situated within a rigid or semi-rigid cap. The edge of the cap wall is adhesively fixed to the tissue surrounding the stoma. The interior of the cap is pressurized to press the membrane to seal the stoma against the discharge of solid and semi-solid waste. Gas escapes through a vent with a filter element. The cap can be pressurized by an external pump or an integral pump member situated on top of the cap. A relief valve prevents over pressurization. A collection pouch can be provided as part of a device. The device can be removably mounted on a standard two-piece faceplate.”
U.S. Patent Application Publication Number 2007/0088300 relates to “a single-use ostomy appliance is described including an ostomy coupling for releasable coupling first and second portions at a stomal orifice. The two portions may be separable body-side and non-body-side parts, or the two portions may be portions of a unitary ostomy device such as a controlled evacuation device. The coupling includes a mechanical fastener configured such that the coupling is rendered substantially not resecurable after the fastener is released.”
U.S. Patent Application Publication Number 2007/0191794 relates to “a controlled evacuation ostomy appliance comprises a membrane that is urged into sealing engagement with a stoma, by the generation of radial tension in the membrane. A tensioning device applies tension, with respect to the stoma, at one or more positions that are (i) outboard of the periphery of the projecting portion of the stoma, and/or (ii) between the level of the peristomal skin and the level of the most projecting part of the stoma. Tension limiting means are disclosed. The membrane may be gas-permeable to allow flatus to be vented.”
U.S. Pat. No. 6,689,111 relates to “a balloon-like member is received in the bowel and inflated to seal the stoma. The member includes a thin, flexible wall defining an opening. A rigid or semi-rigid cap retains the member and closes the opening in the member wall. Skin comfortable adhesive adheres the edge of the cap to the tissue surrounding the stoma. A flexible dilation tube facilitates insertion of the member and cooperates with a pump to inflate the member. The cap is preferably removeably attached to a standard two-piece ostomy faceplate and is provided with a filter element to vent flatus.”